NCT03602573

Liver Fibrosis in Peri-menopausal Women

Nonalcoholic Fatty Liver Disease and Associated Liver Fibrosis in Peri-menopausal Women

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: Female
• Age: 46 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective observational study in a single medical center. The aim is to evaluate the status of fibrosis and steatosis of liver parenchyma in peri-menopausal women using noninvasive methods of vibration-controlled transient elastography (VCTE) with controlled attenuation parameter (CAP) and serum biomarkers. Recruitment period: 2018/08/01 to 2019/07/31 Patient number: 200 females Inclusion criteria: 1. Females, age of 46-55 years 2. Willing and able to comply with the study requirements 3. Willing and able to provide written informed consent to participate in the study Exclusion criteria: 1. Unable to complete the noninvasive procedure of VCET and CAP 2. Unwilling to provide written informed consent to participate in the study Laboratory tests and examinations: Baseline and two follow-up visits (every 6 months): 1. Blood pressure 2. BW, BH, waist circumference, BMI 3. Complete blood cell (CBC) count 4. Albumin, AST, ALT, alkaline phosphatase, total bilirubin, r-GT, uric acid, hsCRP 5. Sugar (fasting), HbA1c, insulin, HOMA-IR 6. DM lipid profiles, adiponectin, leptin 7. Liver ultrasound, FibroScan touch 520 8. FSH, Estrodiol (E2), LH 9. TSH, free T4 10. HBsAg, anti-HCV, HBV DNA, HCV RNA, HBsAg quantification, HBV genotype (if HBsAg or anti-HCV positive) 11. ANA, Anti-mitochondrial antibody 12. Review history of drug and menstruation cycles

Conditions

• Nonalcoholic Steatohepatitis
• Liver Fibroses
• Menopause

Timeline

• Start date: 2018-08-01
• Primary completion: 2019-07-31
• Completion: 2019-07-31
• First posted: 2018-07-27
• Last updated: 2018-08-21

Locations

1 site across 1 country: Taiwan